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Stanislaw Burzynski’s propaganda victory on antineoplastons: The FDA really caves

It’s been a while since I wrote a substantive post for this blog about the Houston cancer doctor and Polish expat Stanislaw Burzynski who claims to have a fantastic treatment for cancer that blows away conventional treatment for cancers that are currently incurable. The time has come—and not for good reasons. The last time was primarily just a post announcing my article about Burzynski being published in Skeptical Inquirer. When last we saw Stanislaw Burzynski on this blog, it was a post that I hated to write, in which I noted that the Food and Drug Administration (FDA) had caved to patient and legislator pressure and allowed compassionate use exemptions (otherwise known as single patient INDs) to continue. The catch? Cynically, the FDA put a condition on its decision, specifically that no doctor associated with Burzynski nor Burzynski himself could administer the antineoplastons. This set off a mad scramble among Burzynski patients wanting ANPs to find a doctor willing to do all the paperwork and deal with Burzynski to administer ANPs. The family of one patient, McKenzie Lowe, managed to succeed.

It’s hard for me to believe that it’s been almost three years since I first started taking an interest in Burzynski. Three long years, but that’s less than one-twelfth the time that Burzynski has been actually been administering an unproven cancer treatment known as antineoplastons (ANPs), a drug that has not been FDA-approved, to patients, which he began doing in 1977. Yes, back when Burzynski got started administering ANPs to patients, I was just entering high school, the Internet as we know it did not exist yet (just a much smaller precursor), and disco ruled the music charts. It’s even harder for me to believe, given the way that Burzynski abuses clinical trial ethics and science, that I hadn’t paid much attention to him much earlier in my blogging career. After all, I’m a cancer surgeon, and here’s been this guy treating patients with advanced brain cancers using peptides that, according to Burzynski, do so much better against what are now incurable tumors than standard of care while charging huge sums of money to patients on “clinical trials.” It might be a cliché to quote the Dead this way, but what a long, strange trip it’s been. Because there has been a major development in this saga whose context you need to know to understand, I’m going to do a brief recap. Long-time regulars, feel free to skip the next couple of paragraphs, as they just try to bring people up to date and include a lot of links for background, or, if you haven’t already, read this summary of Burzynski’s history published earlier this year in Skeptical Inquirer. Newbies, listen up. Read the next two paragraphs. You need to know this to understand why I’m so unhappy. (more…)

Posted in: Cancer, Clinical Trials, Politics and Regulation

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Did Facebook and PNAS violate human research protections in an unethical experiment?

Facebookfail

Ed. Note: NOTE ADDENDUM

I daresay that I’m like a lot of you in that I spend a fair bit of time on Facebook. This blog has a Facebook page (which, by the way, you should head on over and Like immediately). I have a Facebook page, several of our bloggers, such as Harriet Hall, Steve Novella, Mark Crislip, Scott Gavura, Paul Ingraham, Jann Bellamy, Kimball Atwood, John Snyder, and Clay Jones, have Facebook pages. It’s a ubiquitous part of life, and arguably part of the reason for our large increase in traffic over the last year. There are many great things about Facebook, although there are a fair number of issues as well, mostly having to do with privacy and a tendency to use automated scripts that can be easily abused by cranks like antivaccine activists to silence skeptics refuting their pseudoscience. Also, of course, every Facebook user has to realize that Facebook makes most of its money through targeted advertising directed at its users; so the more its users reveal the better it is for Facebook, which can more precisely target advertising.

Whatever good and bad things about Facebook there are, however, there’s one thing that I never expected the company to be engaging in, and that’s unethical human subjects research, but if stories and blog posts appearing over the weekend are to be believed, that’s exactly what it did, and, worse, it’s not very good research. The study, entitled “Experimental evidence of massive-scale emotional contagion through social networks“, was published in the Proceedings of the National Academy of Sciences of the United States of America (PNAS), and its corresponding (and first) author is Adam D. I. Kramer, who is listed as being part of the Core Data Science Team at Facebook. Co-authors include Jamie E. Guillory at the Center for Tobacco Control Research and Education, University of California, San Francisco and Jeffrey T. Hancock from the Departments of Communication and Information Science, Cornell University, Ithaca, NY. (more…)

Posted in: Clinical Trials, Computers & Internet, Neuroscience/Mental Health, Science and the Media

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One Million Page Views

For the first time, ScienceBasedMedicine.org has reached a million page views in a month, thanks to a surge in social media buzz. We’ve come close before, but finally pushed comfortably past that major milestone earlier this week. As of today, SBM served 1,051,943 pages to 649,315 visitors in the last thirty days. These are mainstream-scale numbers: SBM is now competing effectively with many popular websites about not-so-science-based medicine.

Dr. Evil: “One MILLION visits.”

What articles are attracting so much attention? The traffic surge is powered by several popular recent posts, but mostly two of Dr. Gorski’s, about the Food Babe and John Oliver skewering Dr. Oz. Dr. Novella’s Food Fears post isn’t far behind. Other respectable slices of the traffic pie chart include Dr. Hall’s perpetually popular Isagenix post, and Scott Gavura’s coffee enema post — which also happen to be the two busiest SBM pages of all time, with Aspartame — Truth vs Fiction in third place.

graph of one million pageviews

SBM’s inaugural post was on January 1, 2008. Unfortunately, we have no traffic data until the middle of 2013. Since then, we’ve seen a doubling in average monthly traffic. It’s been a team effort, of course, but Facebook and Twitter have been huge factors in that steady growth. Bobby Hannum manages those accounts for us, and somehow manages to post and tweet for us almost every single day while going to medical school. If you haven’t already, please like and follow.

Next stop: a million views per week…

~ Paul Ingraham, Assistant Editor

Posted in: Announcements

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TCM Hodgepodge

acupuncture
I suspect there is more published about traditional Chinese medicine than any other SCAM. Here are some of the recent curiosities of TCM.

Burning genitals

The little girls laughed about the germs, because they didn’t believe in them; but they believed about the disease, because they’d seen that happen. Spirits caused it, everyone knew that. Spirits and bad luck. Jack had not said the right prayers.
- Oryx and Crake

I long ago gave up on the idea that there are a finite number of pseudo-medical treatments. Anything a human can imagine will probably be used as a SCAM intervention. I remain amazed at the permutations that occur in the pseudo-medical world, not unlike the mix and match bioforms in Oryx and Crake.

Not everyone knows basic anatomy and physiology that allows for understanding of disease. Instead, people often rely on metaphor and magic for their understanding, especially in the world of pseudo-medicine. Sympathetic magic lies at the heart of many SCAMs. (more…)

Posted in: Acupuncture, Traditional Chinese Medicine

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NY federal court hands triple loss to anti-vaccination ideology

vacccine preventable disease plane ride away

The state of New York allows religious and medical (but not philosophical) exemptions from school vaccination mandates. New York City has a policy of excluding unvaccinated schoolchildren from classes when there is an outbreak of vaccine-preventable disease reported in a particular school. Two sets of parents whose children had religious exemptions sued New York City and the state in federal court when their children were temporarily excluded from school under the policy, in some cases for up to a month. In other words, they were demanding that their unvaccinated children be allowed to attend even though there was an outbreak of vaccine-preventable disease at the school.

These cases were consolidated with another filed by parents, the Checks, who claimed their child had been improperly denied a religious exemption. The parents had applied for a medical exemption, which was denied, as well as a religious exemption, which was granted, but then revoked. (The record is somewhat confusing on this sequence of events, but that sequence is not relevant to our discussion.) The unvaccinated child was ultimately sent to a private school, even though she should have been excluded from admission under New York City law there as well.

Last week, a federal judge dismissed all three cases (they had been consolidated and assigned to one judge) in an opinion holding that neither the students’ nor the parents’ constitutional rights were violated, including their First Amendment right to free exercise of religion. The plaintiffs have filed an appeal. (more…)

Posted in: Critical Thinking, Legal, Politics and Regulation, Public Health, Religion, Vaccines

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Food Fears

all natural banana

A new Cornell University study examines the origins of food fears, and possible remedies. It’s a survey of 1,008 mothers asking about foods they avoid and why.

Food fears are a common topic on SBM, likely for several reasons. Humans have an inherent emotion of disgust, which is likely an adaptation to help avoid contaminated or spoiled food. In our modern society this reflex can be tricky, because we do not always have control over the chain of events that leads to food on our plates. Other people grow the food, transport it, process it, and perhaps even cook it.

Modern food technology can also involve many scary sounding substances and unusual processes. As the saying goes, you may not want to know how the sausage is made, as long as the end result is wholesome.

This leads to a second reason for modern food fears – we are living in an age of increasing transparency, partly brought about by the dramatic increase in access to information on the internet. I think ultimately this is a good thing – people are seeing how the sausage is made, which makes it more difficult to hide shady practices. This introduces a new problem, however. If you’re going to inspect the process of making sausage, then you need to know something about sausage-making. (more…)

Posted in: Nutrition

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Acupuncture for Macular Degeneration: Why I Reject the Evidence

This post is dedicated to two people who are frequent commenters on SBM, Stephen S. Rodrigues and Peter Moran. Rodrigues is an MD/acupuncturist who tries to persuade us that acupuncture is effective. Moran is a retired surgeon who objects to insulting language and thinks more can be accomplished by trying to better understand why people turn to CAM and by explaining the facts and reasons politely and dispassionately. He has claimed that he “could probably help [Rodrigues] understand better why his views are not having much impact.”

I recently wrote about supplements for age-related macular degeneration (AMD). There is evidence that the supplement mixture tested in the AREDS trial slows the progression of moderate to advanced disease. That is based on a good scientific study, although the study has not been replicated and there is reason to interpret its results with caution. Dr. Rodrigues commented with a link to a website advertising the Santa Fe acupuncture protocol, saying that he uses the method in his office and it helps some of his patients with AMD. The website claims that the Santa Fe acupuncture protocol will reverse vision loss from macular degeneration in 4 days or your money back. That is a bold claim. I will try to explain, as politely as possible, why I reject the claim, and why the evidence for it is unacceptable. (more…)

Posted in: Acupuncture, Clinical Trials, Ophthalmology

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John Oliver skewers Dr. Oz for his hawking of diet supplements

As regular readers of this blog know, Dr. Mehmet Oz had a very, very bad day last week, in which he received a major tongue lashing from Senator Claire McCaskill (D-MO) for the scientifically unsupported and irresponsible hyperbole he dishes out day after day on his syndicated daytime television show. Personally, I was tempted to pile on myself, but had to content myself with enjoying a couple of posts from a super secret blog in the run-up to the hearing (inviting Dr. Oz to testify is “like asking Al Capone to testify about U.S. tax policy or Stanislaw Burzynski about clinical trial design and ethics”), right after the hearing, and looking at the fallout from the hearing. I had even thought of asking my “friend” to combine the last two into an SBM-worthy post, but by the time that thought had occurred to me, the moment had passed.

One of the best takes I’ve seen on the whole “Oz-fest” last week comes from John Oliver on his HBO show Last Week Tonight With John Oliver. It’s a really long segment that takes up the last half of his show and features—don’t ask why—George R. R. Martin and a tap dancing Steve Buscemi. It’s hilariously spot on:

Most SBM readers will enjoy it. I promise. Oliver even correctly identifies Sen. Orrin Hatch (R-UT) and Tom Harkin (D-IA) as tools of the supplement industry and explains why dietary supplements in the U.S. are largely unregulated and the FDA and FTC have such limited powers to do anything about them preemptively.

Posted in: Herbs & Supplements, Humor, Nutrition, Science and the Media

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Ketogenic diet does not “beat chemo for almost all cancers”

One of the difficult things about science-based medicine is determining what is and isn’t quackery. While it is quite obvious that modalities such as homeopathy, acupuncture, reflexology, craniosacral therapy, Hulda Clark’s “zapper,” the Gerson therapy and Gonzalez protocol for cancer, and reiki (not to mention every other “energy healing” therapy) are the rankest quackery, there are lots of treatments that are harder to classify. Much of the time, these treatments that seemingly fall into a “gray area” are treatments that have shown promise in animals but have never been tested rigorously in humans or are based on scientific principles that sound reasonable but, again, have never been tested rigorously in humans. (Are you sensing a pattern here yet?) Often these therapies are promoted by true believers whose enthusiasm greatly outstrips the evidence base for their preferred treatment. Lately, I’ve been seeing just such a therapy being promoted around the usual social media sources, such as Facebook, Twitter, and the like. I’ve been meaning to write about it for a bit, but, as is so often the case with my Dug the Dog nature—squirrel!—other topics caught my attention.

I’m referring to a diet called the ketogenic diet, and an article that’s been making the rounds since last week entitled “Ketogenic diet beats chemo for almost all cancers, says Dr. Thomas Seyfried.” Of course, when I see a claim such as that, my first reaction is, “Show me the evidence.” My second reaction is, “Who is this guy?” Well, Dr. Seyfried is a professor of biology at Boston College, who’s pretty well published. He’s also working in a field that has gained new respectability over the last five to ten years, namely cancer metabolism, mainly thanks to a rediscovery of what Otto Warburg discovered over 80 years ago. What Warburg discovered was that many tumors rely on glycolysis for their energy even in environments with adequate oxygen for oxidative phosphorylation, which generates the bulk of the chemical energy used by cells. I described this phenomenon in more detail in a post I did four years ago about a drug that looks as though its anticancer properties come from its ability to reverse the Warburg effect. (more…)

Posted in: Basic Science, Cancer, Nutrition, Science and the Media

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Is There a Role for the Art of Medicine in Science-Based Practice?

Bushpainting

The practice of medicine is an art, not a trade; a calling, not a business; a calling in which your heart will be exercised equally with your head.

The practice of medicine is an art, based on science.

-Sir William Osler, AEQUANIMITAS

The truth is that many of us have some kind of “extraordinary gift.” For a few of us, that gift is the ability to throw a ball at 90 miles per hour and hit a catcher’s glove. For others, that gift is a form of extraordinary perception. Medical intuitives “see” things that others don’t. Wendy Marks has been described as a “human CT scan.” What no one has been able to diagnose by conventional methods is often seen when Wendy scans a body.

-Boston Women’s Journal April/May 2002

The concept of an art to the practice of medicine comes up frequently and in a variety of contexts. Early on in our medical education, we are exposed to the phrase and what it supposedly means, which I will discuss in more detail shortly. But the art of medicine is always painted (pun intended) in a positive light. I will admit that I have a strong opinion, perhaps biased by my involvement with the science-based medicine movement and an equally early exposure during my medical training to champions of evidence-based practice and the use of critical thinking in the approach to patient care.
(more…)

Posted in: Science and Medicine

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